Assistive ExoSkeleton and ExoTendon System for Increased Return of Limb Function after Diabetic Foot Ulcer

辅助外骨骼和外肌腱系统可增强糖尿病足溃疡后肢体功能的恢复

• 批准号: 10258894
• 负责人: Mark C Roser
• 金额: $ 87.04万
• 依托单位: RESULTS GROUP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-17 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258894
• 关键词: 3D Print; Adherence; Aftercare; Amputation; Anxiety; Area; Award; Back; Blood; Budgets; Cancer Survivor; Caring; Cellular Phone; Chronic Disease; Clinical; Clinical effectiveness; Control Groups; Data; Devices; Diabetes Mellitus; Diabetic Foot Ulcer; Ecological momentary assessment; Effectiveness; Elderly; Engineering; Ensure; Equilibrium; Evaluation; Fatigue; Feedback; Feeling; Floor; Foot Ulcer; Fostering; Frequencies; Funding; Future; Gait; Gait speed; Goals; Habilitation; Healthcare Systems; Home; Hour; Independent Living; Individual; Institutes; Instruction; International; Learning; Leg; Legal patent; Length; Limb structure; Lower Extremity; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Measures; Medical; Mental Depression; Mission; Motor; National Institute of Nursing Research; Operative Surgical Procedures; Participant; Patients; Persons; Phase; Physical Function; Physical activity; Prevalence; Prevention; Production; Property; Quality of life; Randomized; Recurrence; Rehabilitation therapy; Research; Risk; Robotics; Scanning; Secondary Prevention; Self-Help Devices; Shelter facility; Shoes; Small Business Innovation Research Grant; Spottings; Structure; System; Tendon structure; Testing; Time; Ulcer; United States National Institutes of Health; Universities; Walking; Work; achilles tendon; ankle joint; base; clinically significant; control trial; cost; design; diabetic; disability; exoskeleton; experience; fall risk; follow-up; foot; group intervention; healing; high risk; improved; innovation; invention; light weight; limb amputation; member; mortality; mortality risk; multidisciplinary; novel; phase 1 study; phase 1 testing; phase I trial; pressure; primary outcome; prototype; psychosocial; rehabilitation research; research clinical testing; restoration; robot rehabilitation; secondary outcome; sensor; skin irritation; social; social metrics; standard of care; technology development; walking speed; wound closure; wound healing

Project Summary / Abstract Relatedness to Mission: Application aligns with 2019 Supplemental Goals for both NINR & NIA.: NINR: Assistive…devices that can… improve quality of life for individuals with chronic diseases/conditions NIA: Development of technologies/robotics to assist in the improvement of physical function and mobility in older persons prior to (pre-habilitation) or following (rehabilitation) elective/planned surgery Medical need: This application focuses on secondary prevention of diabetic foot ulcer (DFU) when patients are most vulnerable. DFU is the leading cause of amputation, more costly than the most expensive cancer, and survivors of lower limb amputation have a higher mortality rate than half of the top 10 cancers. Invention: Together with patient input, team has designed a novel assistive exoskeleton that has been shown in Ph I studies to off-load pressure from the foot by deploying a disruptive design for rehabilitation robotics. It integrates a structural exo-skeleton to externalize lower limb forces outside of the body. In two Phase I studies, the exoskeleton has demonstrated reduction of force under the forefoot. Unexpectedly, the device has also demonstrated improved propulsion by increasing stride length and walking speed concurrent to reducing plantar pressures. The device has received enthusiastic patient feedback from multiple participants who enjoyed feeling a “spring in their step” and showed no negative impact on measures of fall risk. Aim 1) Product Refinement Engineering: Team will improve upon Ph I prototypes to overcome issues with comfort and to ensure durability and robustness. Aim 2) Motor Restoration of Gait & Balance, Activity, Psycho-Social: The prototypes will be evaluated for their ability to help restore clinical gait function and balance at 1, 3 and 6 months after completion of wound healing subsequent to DFU treatment as well as their impact on the restoration of daily physical activity level and psycho social measures. Efficacy (recurrence rates) are beyond the available budget of SBIR and will be pursued with collaborative university led research. Rationale: The team recently completed two Phase I SBIR funded studies through NIH/National Institute of Nursing Research and ACL/National Institute for Disability, Independent Living and Rehabilitation Research. Results show that the prototypes were able to off-load significant pressure by externalizing forces. Team has been awarded 4 issued US patents and international IP. If successful, this will be the first disruptive innovation in off-loading in decades and illuminates key design factors for future evaluation of robotic off- loading devices and sensor controlled devices.

项目总结/摘要 与使命的相关性：应用程序与NINR和NIA的2019年补充目标保持一致。： NINR：辅助.设备，可以.改善慢性疾病/病症患者的生活质量 NIA：开发技术/机器人技术，以帮助改善身体功能和行动能力， 择期/计划手术之前（术前）或之后（康复）的老年人 医疗需求：该应用程序侧重于糖尿病足溃疡（DFU）的二级预防， 是最脆弱的。DFU是截肢的主要原因，比最昂贵的癌症更昂贵， 下肢截肢幸存者的死亡率高于前10种癌症的一半。 发明：与患者输入一起，团队设计了一种新型的辅助外骨骼， 在Ph I研究中，通过部署康复机器人的破坏性设计来减轻足部压力。它 集成了结构外骨骼，以将下肢力外化到体外。在两项I期研究中， 外骨骼已经证明了前足下的力的减小。出乎意料的是，该设备还 通过增加步幅和步行速度同时减少 足底压力该设备已经收到了来自多名参与者的热情患者反馈， 他们喜欢感觉“脚步轻快”，对跌倒风险的测量没有负面影响。 目标1）产品优化工程：团队将改进I期原型，以克服以下问题： 舒适性，并确保耐用性和坚固性。 目标2）步态和平衡，活动，心理社会的运动恢复：将对原型进行评估， 在伤口愈合后1、3和6个月时帮助恢复临床步态功能和平衡的能力 DFU治疗后的愈合及其对恢复日常体力活动水平的影响 和心理社会措施。疗效（复发率）超出SBIR的可用预算， 以大学为主导的合作研究。 理由：该团队最近通过NIH/国家卫生研究所完成了两项SBIR资助的I期研究。 护理研究和ACL/国家残疾，独立生活和康复研究所。 结果表明，原型能够卸载显着的压力，通过外力。团队 获得4项美国专利和国际知识产权。如果成功，这将是第一个 几十年来在卸载方面的创新，并阐明了未来评估机器人卸载的关键设计因素， 加载装置和传感器控制装置。